Made Scientific
About Made Scientific
Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Operating from two U.S.-based manufacturing facilities, Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.
Position Summary The Manufacturing Support Associate sustains GMP readiness of Made Scientific cleanrooms by executing routine and ad-hoc facility sanitization, performing viable and non-viable environmental monitoring, and supporting material/equipment/product flow throughout the facility. The role is highly detail-oriented, documentation-driven, and integral to contamination control and patient safety.
Key Responsibilities Cleanroom Cleaning & Sanitization (50% of time) • Perform routine scheduled and ad hoc cleaning of classified cleanrooms in accordance with SOPs, cGMP requirements, and regulatory expectations • Accurately complete cleaning logs and documentation to ensure GDP compliance • Support inspection readiness by maintaining cleanroom standards and addressing deviations promptly Environmental Monitoring (25% of time) • Conduct viable and non-viable environmental monitoring (e.g., settle plates, contact plates, active air sampling, and particle counts) across classified areas • Document EM results in accordance with SOPs, ensuring accurate data collection and traceability • Coordinate with Quality Control for submission, tracking, and follow-up of EM samples Production Support (25% of time) • Safely transfer raw materials, consumables, drug product, and equipment throughout the facility including classified locations • Support material staging and preparation to enable timely manufacturing operations • Assist production staff with ancillary support tasks as needed, such as cryopreservation transfer tasks Compliance & Continuous Improvement • Adhere strictly to GMP, GDP, and safety requirements during all activities • Comply with all local policies and SOPs governing tasks performed • Maintain training status including aseptic gowning qualification and requalification • Identify and escalate any deviations or anomalies observed during cleaning, EM, or material handling • Participate in training, audits, and continuous improvement initiatives such as 5S/Kaizen to sustain a culture of quality and compliance
Required Qualifications • Associate’s degree with 1–3 years of experience in a GMP-regulated pharmaceutical, biotech, or CDMO environment • Knowledge of aseptic technique, contamination control principles, and cleanroom operations • Familiarity with environmental monitoring methods and good documentation standards • Strong attention to detail with proven ability to follow SOPs and GDP requirements • Strong teamwork and communication skills with flexibility to support cross-functional needs
Preferred Qualifications • Bachelor’s degree in a science-based discipline (e.g., biology, chemistry, biotechnology) • Prior experience with cleanroom sanitization, environmental monitoring execution, and/or materials handling is strongly preferred
Physical Requirements • Ability to sit or stand for extended periods and perform repetitive tasks in a cleanroom environment • Capable of lifting up to 25 lbs and working in cleanroom gowning and PPE for prolonged periods • Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other federal, state, and local standards, including meeting productivity standards • Ability to maintain regular, punctual attendance consistent with ADA, FMLA, and other federal, state, and local standards • Must be willing to handle cell-based products, chemicals, or hazardous materials
Work Schedule • Shiftwork required, including off-shift hours, weekends, and holidays as needed to meet production demands • Primary location: Princeton, NJ facility, with travel to the Newark, NJ facility up to 50% during peak periods of activity based on business needs
Position Summary The Manufacturing Support Associate sustains GMP readiness of Made Scientific cleanrooms by executing routine and ad-hoc facility sanitization, performing viable and non-viable environmental monitoring, and supporting material/equipment/product flow throughout the facility. The role is highly detail-oriented, documentation-driven, and integral to contamination control and patient safety.
Key Responsibilities Cleanroom Cleaning & Sanitization (50% of time) • Perform routine scheduled and ad hoc cleaning of classified cleanrooms in accordance with SOPs, cGMP requirements, and regulatory expectations • Accurately complete cleaning logs and documentation to ensure GDP compliance • Support inspection readiness by maintaining cleanroom standards and addressing deviations promptly Environmental Monitoring (25% of time) • Conduct viable and non-viable environmental monitoring (e.g., settle plates, contact plates, active air sampling, and particle counts) across classified areas • Document EM results in accordance with SOPs, ensuring accurate data collection and traceability • Coordinate with Quality Control for submission, tracking, and follow-up of EM samples Production Support (25% of time) • Safely transfer raw materials, consumables, drug product, and equipment throughout the facility including classified locations • Support material staging and preparation to enable timely manufacturing operations • Assist production staff with ancillary support tasks as needed, such as cryopreservation transfer tasks Compliance & Continuous Improvement • Adhere strictly to GMP, GDP, and safety requirements during all activities • Comply with all local policies and SOPs governing tasks performed • Maintain training status including aseptic gowning qualification and requalification • Identify and escalate any deviations or anomalies observed during cleaning, EM, or material handling • Participate in training, audits, and continuous improvement initiatives such as 5S/Kaizen to sustain a culture of quality and compliance
Required Qualifications • Associate’s degree with 1–3 years of experience in a GMP-regulated pharmaceutical, biotech, or CDMO environment • Knowledge of aseptic technique, contamination control principles, and cleanroom operations • Familiarity with environmental monitoring methods and good documentation standards • Strong attention to detail with proven ability to follow SOPs and GDP requirements • Strong teamwork and communication skills with flexibility to support cross-functional needs
Preferred Qualifications • Bachelor’s degree in a science-based discipline (e.g., biology, chemistry, biotechnology) • Prior experience with cleanroom sanitization, environmental monitoring execution, and/or materials handling is strongly preferred
Physical Requirements • Ability to sit or stand for extended periods and perform repetitive tasks in a cleanroom environment • Capable of lifting up to 25 lbs and working in cleanroom gowning and PPE for prolonged periods • Ability to safely and successfully perform essential job functions consistent with ADA, FMLA, and other federal, state, and local standards, including meeting productivity standards • Ability to maintain regular, punctual attendance consistent with ADA, FMLA, and other federal, state, and local standards • Must be willing to handle cell-based products, chemicals, or hazardous materials
Work Schedule • Shiftwork required, including off-shift hours, weekends, and holidays as needed to meet production demands • Primary location: Princeton, NJ facility, with travel to the Newark, NJ facility up to 50% during peak periods of activity based on business needs